Hydroxychloroquine and tocilizumab therapy in COVID-19 patients—An observational study
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SciScore for 10.1101/2020.05.21.20109207: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: (Fig. 1) Institutional Review Board (IRB) approval was obtained for the observational database.
Consent: Informed consent was waived by the IRB as this represented a non-interventional study of routinely collected data used for secondary research purposes.Randomization Patients were included in the database based on the following inclusion and exclusion criteria: 1) Positive SARS-CoV-2 diagnosis by reverse-transcriptase polymerase chain reaction, 2) Hospitalized within the time frame of March 1, 2020 until May 5, 2020, 3) Non-pregnant, 4) Not on a randomized clinical trial, and 5) Did not die during first day of hospitalization, and 5) Were not discharged … SciScore for 10.1101/2020.05.21.20109207: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: (Fig. 1) Institutional Review Board (IRB) approval was obtained for the observational database.
Consent: Informed consent was waived by the IRB as this represented a non-interventional study of routinely collected data used for secondary research purposes.Randomization Patients were included in the database based on the following inclusion and exclusion criteria: 1) Positive SARS-CoV-2 diagnosis by reverse-transcriptase polymerase chain reaction, 2) Hospitalized within the time frame of March 1, 2020 until May 5, 2020, 3) Non-pregnant, 4) Not on a randomized clinical trial, and 5) Did not die during first day of hospitalization, and 5) Were not discharged to home within 24 hours. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data abstracted by the team was entered using REDCap (Research Electronic Data Capture) hosted at HMH [26,27]. REDCapsuggested: (REDCap, RRID:SCR_003445)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Limitations: Multiple RCT’s will ultimately determine the efficacy of hydroxychloroquine and tocilizumab in COVID-19. This observational study has limitations. First, observational studies cannot draw causal inferences given inherent known and unknown confounders. We attempted to adjust for known confounders using our propensity model approach. Second, misclassification is possible as we performed manual abstraction of EHR data. Third, low sample size limited our exploratory tocilizumab analysis. Fourth, our study focused on patients in New Jersey, limiting the applicability to other geographic regions, although the state’s population is diverse, and the network included 13-hospitals (both academic and community) all with differing COVID-19 treatment protocols. Lastly, we acknowledge the possibility of sampling bias as we collected data from a convenience sample in attempts to conduct the investigation quickly during this pandemic.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04347993 Recruiting A Prospective "Universal" Observational Database for COVID-1… NCT04331808 Active, not recruiting CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI) Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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